A Randomized Controlled Trial of the Feasibility and Acceptability of W-GenZD Versus CBT-light Teletherapy for Adolescents Seeking Mental Health Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale
研究概览
简要总结
The primary aim of this study is to determine the feasibility and acceptability of the W-GenZD mobile application among a group of adolescents and who have screened and triaged into low-intensity treatment within the Children's Hospital of the King's Daughters. The secondary aim of this study is to determine the preliminary comparative efficacy of W-GenZD and CBT-light teletherapy zoom groups to manage mood concerns at 4-weeks end of treatment relative to baseline. The third aim of this study is to investigate potential differences between group differences on working alliance. An exploratory aim of this study is to observe and describe the utilization and outcomes of the safety procedures utilized within this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed triage at the Children's Hospital of the King's Daughters (CHKD) and have been deemed appropriate for the low-intensity intervention track, given presenting problem(s) of depressive or anxiety symptoms
- •Adolescent 13-17 years of age, inclusive
- •U.S. resident
- •Both adolescent participant and parent/guardian are able to read and write in English
- •Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), that can receive SMS messages, and reliable Wi-Fi access or sufficient data to engage with assigned treatment condition for the duration of the study
- •If currently prescribed antidepressant medications (e.g. escitalopram/Lexapro, fluoxetine/ Prozac), antipsychotic medications (e.g. aripiprazole, asenapine, olanzapine, paliperidone, quetiapine, risperidone), or stimulants (e.g. amphetamine/Adderall, Methylphenidate/Ritalin) and alpha agonists (e.g. atomoxetine/Strattera, Guanfacine/Intuniv) they are at a regular, stable dose for at least 60 days at screening
- •Not currently actively engaged is psychotherapy
- •Available and committed to engage with the program and complete assessments for a 8-week duration
- •Family is willing and able to engage in discussion of safety planning in the event of suicidal symptoms
排除标准
- •Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- •Lifetime diagnosis of bipolar disorder
- •Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome)
- •Current diagnosis of developmental delay or intellectual disability
- •Suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
- •History of (a) drug and/or alcohol abuse within the past 12 months
- •Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
- •Previous Woebot application use
- •Enrollment of more than one member of the same household
结局指标
主要结局
Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale
时间窗: End-of-treatment (4 weeks from baseline)
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Items (e.g., "The total time required to do the treatment procedures was manageable") are rated on a 6-point Likert scale (1 = "strongly disagree" to 6 = "strongly agree"). Total feasibility scores range from 6-36, with higher scores indicating greater intervention feasibility with the W-GenZD mobile application or the CBT-Lite teletherapy groups.
Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale
时间窗: End-of-treatment (4 weeks from baseline)
Measure of acceptability. A 9-item subscale that inquires about intervention acceptability. For the purposes of this study, an adapted 6-item version of the subscale was utilized. Items (e.g., "This treatment is an effective choice for addressing a variety of depression concerns) are rated on a 6-point Likert scale (1 = "strongly disagree" to 6 = "strongly agree"). Total acceptability scores range from 6-36, with higher scores indicating greater intervention acceptability with the W-GenZD mobile application or the CBT-Lite teletherapy groups.
次要结局
- Patient Health Questionnaire, 8 Items (PHQ-8)(Baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks)